| Title: | Full-spectrum extract from Cannabis sativa DKJ127 for chronic low back pain: a phase 3 randomized placebo-controlled trial |
| Authors: | Matthias Karst, Winfried Meissner, Sabine Sator, Jens Keßler, Volker Schoder & Winfried Häuser |
| Year: | 2026 |
| Journal: | Nature Medicine |
A new multicenter, randomized, placebo-controlled Phase 3 trial published in Nature Medicine evaluated the efficacy and safety of a standardized, full-spectrum, orally administered cannabis extract (VER-01), for the treatment of chronic low back pain (CLBP). Given the limitations and risks associated with current pharmacological options like opioids and NSAIDs, this study addresses a critical need for safe and effective alternatives.
The trial enrolled 820 adults with CLBP, randomizing them to receive either the cannabis extract (containing 5% THC and a standardized profile of terpenes and minor cannabinoids) or a matching placebo. The study utilized a rigorous design comprising a 12-week double-blind treatment period (Phase A), followed by a 6-month open-label extension (Phase B), and a randomized withdrawal phase (Phase D) to assess durability and maintenance of effect.
Participants titrated to their optimal dose during the initial phase of the study. During the Phase A treatment period, the mean daily dose in the active treatment group was 7.62 dose units, corresponding to approximately 19 mg of THC per day.
Key Efficacy Findings: The study met its primary endpoint in Phase A, with the cannabis extract demonstrating superior pain reduction compared to placebo. Specifically, participants in the cannabis extract group experienced a mean reduction of 1.9 points on the Numeric Rating Scale (NRS; 0-10), resulting in a significant mean difference of -0.6 points versus placebo (95% CI = -0.9 to -0.3; P < 0.001).
The results were particularly notable for participants with a neuropathic pain component. For this subgroup, the total Neuropathic Pain Symptom Inventory (NPSI; 0-100) score decreased by a mean of 14.4 points in the cannabis extract arm, showing a significant mean difference of -7.3 points compared to placebo (95% CI = -13.2 to -1.3; P = 0.017).
Clinically meaningful relief was common: the rate of participants achieving a ≥30% reduction in pain was significantly higher in the cannabis extract group (54.1%) compared to placebo (39.5%). This translates to a Number Needed to Treat to Benefit (NNTB) of 6.8 (95% CI = 4.42–15.05; P < 0.001), a favorable metric in chronic pain management. Importantly, efficacy was sustained over the long term, with pain scores decreasing further during the 6-month open-label extension.
Beyond pain intensity, the treatment offered broader quality-of-life benefits. Participants receiving the cannabis extract reported significant improvements in both sleep quality and physical function compared to those on placebo, addressing two of the most debilitating aspects of chronic back pain.
Safety & Tolerability: While side effects were more frequent with treatment, they were generally manageable. In Phase A, treatment-emergent adverse events (TEAEs) were reported by 83.3% of participants in the cannabis extract group versus 67.3% in the placebo group (P < 0.001). The majority of these events were mild to moderate and transient. The most common adverse events (occurring in ≥10% of participants in the cannabis extract arm) included dizziness, headache, fatigue, nausea, dry mouth, and somnolence. There were no signs of dependence or withdrawal symptoms upon cessation of the drug.
Overall, these Phase 3 results suggest that this full-spectrum cannabis extract may represent a promising, effective therapeutic option for chronic low back pain.
Read the full publication here.
Citation: Karst, M., Meissner, W., Sator, S. et al. Full-spectrum extract from Cannabis sativa DKJ127 for chronic low back pain: a phase 3 randomized placebo-controlled trial. Nat Med 31, 4189–4196 (2025). https://doi.org/10.1038/s41591-025-03977-0